EN    EN EN EN    EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels, XX.Y.2008 
XXX 
  
Draft 
COMMISSION REGULATION (EC) No …/.. 
of  
amending Regulation (EC) No 1907/2006 of the European Parliament and of the 
Council on the Registration, Evaluation,  Authorisation and Restriction of 
Chemicals (REACH) as regards Annex XI  EN 2   EN Draft 
COMMISSION REGULATION (EC) No …/.. 
of 
amending Regulation (EC) No 1907/2006 of the European Parliament and of the 
Council on the Registration, Evaluation,  Authorisation and Restriction of 
Chemicals (REACH) as regards Annex XI  
(Text with EEA relevance) 
THE COMMISSION OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty esta blishing the European Community,  
Having regard to Regulation (EC) No 1907/2006 of 18 December 2006 of the European 
Parliament and of the Council concerning the Registration, Evaluation, Authorisation and 
Restriction of Chemicals (REA CH), establishing a European Chemicals Agency, amending 
Directive 1999/45/EC and repealing Council  Regulation (EEC) No 793/93 and Commission 
Regulation (EC) No 1488/94 as  well as Council Directive 76/769/EEC and Commission 
Directives 91/155/EEC, 93/67/ EEC, 93/105/EC and 2000/21/EC1, and in particular Article 
131 thereof,  
Whereas: (1) Regulation (EC) No 1907/2006 establishes re gistration obligations of Community 
manufacturers or importers of substances on their own, in prepar ations or articles, 
where, as part of the registration dossier, registrants have to pr ovide the information 
required under Annexes VI to XI.  
(2) Annex XI allows registrants, under certain  conditions, to omit testing in accordance 
with sections 8.6. and 8.7. of Annex VIII a nd in accordance with Annex IX and Annex 
X to Regulation (EC) No 1907/2006.  
(3) For the avoidance of doubt, it should be clarif ied that in section 3.1 the reference to 
sections 8.6. and 8.7. refers to Annex VIII only. 
(4) It is necessary to establish the criteria defi ning what constitutes ad equate justification 
for the omission of testing under Secti ons 8.6. and 8.7. of Annex VIII and in 
accordance with Annex IX and Annex X to Regulation (EC) No 1907/2006.  
                                                
 
1 OJ L 396, 30.12.2006, p. 1. Regulation as corrected by OJ L 136, 29.5.2007, p.3. and amended by 
Regulation (EC) No 1354/2007 (OJ L 304, 22.11.2007, p. 1). EN 3   EN (5) Based on experience gained through the de velopment of guidance for the chemicals 
safety assessment under Regulation (EC) No 1907/2006, three different criteria for 
exposure-based waiving have been identifie d. The first criterion re quires that it is 
demonstrated and documented that exposur e in all scenarios is well below an 
appropriate DNEL or PNEC derived under specific conditions. The second criterion 
requires that it is demonstrated and docum ented that strictly controlled conditions 
apply throughout the life-cycle . The third criterion requires that where the substance is 
incorporated in an article, th e substance is incorporated in such a way that no exposure 
can take place and the substa nce is not released during its life cycle and is handled 
under strictly controlled conditions duri ng all manufacturing and production stages. 
Consequently, these criteria for justificat ion for the omission of testing should be 
incorporated in Regulation (EC) No 1907/2006.  
(6) Regulation (EC) No 1907/2006 should therefore be amended accordingly. 
(7) The measures provided for in this Regulati on are in accordance with the opinion of the 
Committee established under Article 133 of Regulation (EC) No 1907/2006. 
 HAS ADOPTED THIS REGULATION: 
Article 1 
Annex XI to Regulation (EC) No 1907/2006 is amended in accordance with the Annex to this 
Regulation.  
Article 2 
This Regulation shall enter into  force on the third day following that of its publication in the 
Official Journal of the European Union .  
 
 Done at Brussels, 
For the Commission 
Stavros DIMAS   
Member of the Commission  EN 4   EN ANNEX  
Section 3 of Annex XI to Regulation (E C) No 1907/2006 is replaced by the following: 
 3. SUBSTANCE-TAILORED EXPOSURE-DRIVEN TESTING 3.1. Testing in accordance with Sections 8.6 and 8.7 of Annex VIII and in accordance 
with Annex IX and Annex X may be omitted, based on the exposure scenario(s) developed in the Chemical Safety Report. 
3.2.  In all cases, adequate justificatio n and documentation shall be provided. The 
justification shall be based on a thor ough and rigorous exposure assessment in 
accordance with section 5 of  Annex I and shall meet any one of the following 
criteria:  
(a) the manufacturer or importer demonstr ates and documents that all of the 
following conditions are fulfilled: 
(i) the results of the e xposure assessment covering all relevant exposures 
throughout the life-cycle of the substance demonstrate the absence of or no significant exposure in all scenarios of the manufactu re and all  identified 
uses  as referred to in Annex VI section 3.5; 
(ii) a DNEL or a PNEC can be derived from  results of available test data for the 
substance concerned taking full account of the increased uncertainty resulting from the omission of the information requirement, and that DNEL or PNEC is relevant and appropriate both to the in formation requirement to be omitted 
and for risk assessment purposes;
1 
(iii) the comparison of th e derived DNEL or PNEC with the results of the 
exposure assessment shows that exposures  are always well below the derived 
DNEL or PNEC.  
(b) where the substance is not incorporated in an article the manufacturer or importer 
demonstrates and documents for all rele vant scenarios that throughout the life-
cycle strictly controlled c onditions as set out in Artic le 18(4) (a) to (f) apply. 
(c) where the substance is incorporated in an article in which it is permanently 
embedded in a matrix or otherwise rigorous ly contained by techni cal means, it  is 
demonstrated and documented that all of the following conditions are fulfilled: 
(i)  the substance is not re leased during its life-cycle; 
                                                 
1 For the purpose of sub-paragraph 3;2. a (ii), without prejudice to column 2 of Section 8.7 of Annexes IX and X, 
a DNEL derived from a screening test for reproductiv e/developmental toxicity shall not be considered 
appropriate to omit a prenatal developmental toxicity study or a two-generation reproductive toxicity 
study. For the purpose of sub-paragraph 3;2. a (ii), without prejudice to column 2 of Section 8.6 of 
Annexes IX and X, a DNEL derived from a 28 days repeated dose toxicity study shall not be considered appropriate to omit a 90 days repeated dose toxicity study.  EN 5   EN (ii) the likelihood that wo rkers or the general public  or the environment are 
exposed to the substance under normal or reasonably foreseeable conditions of use is negligible; and 
(iii) the substance is handled accordi ng to the conditions set out in Article 
18(4)(a) to (f) during all manufacturing and production stages including  the 
waste management of the subs tance during these stages.  
3.3.  The specific conditions of use must be communicated through the supply chain in 
accordance with Article 31 or  32, as the case may be.